Skip to main content
U.S. flag

An official website of the United States government

HHS Guidance Portal

The Guidance Portal is a public website that shows current guidance documents from the U.S. Department of Health and Human Services (HHS) and its Divisions.

Filter Guidance Documents by ...

HHS Guidance Documents
Title OpDiv/StaffDiv Guidance Status Issue Date
Pharmacogenomic Data Submissions: Guidance for Industry  Food and Drug Administration (FDA) Final
Pharmacokinetic-Based Criteria for Supporting Alternative Dosing Regimens of Programmed Cell Death Receptor-1 (PD-1) or Programmed Cell Death-Ligand 1 (PD-L1) Blocking Antibodies for Treatment of Patients with Cancer: Guidance for Industry  Food and Drug Administration (FDA) Final
Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol: Guidance for Industry  Food and Drug Administration (FDA) Final
Population Pharmacokinetics: Guidance for Industry  Food and Drug Administration (FDA) Final
Pre-Launch Activities Importation Requests (PLAIR): Guidance for Industry  Food and Drug Administration (FDA) Final
Preclinical Assessment of Investigational Cellular and Gene Therapy Products: Guidance for Industry  Food and Drug Administration (FDA) Final
Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS): Guidance for Industry  Food and Drug Administration (FDA) Final
Premarketing Risk Assessment: Guidance for Industry  Food and Drug Administration (FDA) Final
Premenopausal Women with Breast Cancer: Developing Drugs for Treatment: Guidance for Industry  Food and Drug Administration (FDA) Final
Preparation and Public Availability of Information Given to Advisory Committee Members: Guidance for Industry  Food and Drug Administration (FDA) Final
This Guidance Portal contains 4741 documents.